FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TLS SURGICAL MARKER
K Number: K831372
·
Decision Jun 24, 1983
Classifications
1
FEI Numbers
183
Registration Numbers
184
Same Product Code
22
Applicant Total
15
Review Days
58
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Basic Information
- Device Name
- TLS SURGICAL MARKER
- K Number
- K831372
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4660
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Porex Medical
- Date Received
- April 27, 1983
- Decision Date
- June 24, 1983
- Product Code
- FZZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FZZ | Marker, Skin | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZZ), ordered by most recent decision date.
SURGICHIP TAG SURGICAL MARKER
FDA 510(k)
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DISPOSABLE SKIN MARKER
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BLOOM TRANSPARENT STENCIL
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FDA Class 1
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ROCKET SURGICAL SKIN MARKING PEN
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FDA Class 1
·General, Plastic Surgery
SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUALTEX SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Porex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K872791 | POREX NERVE LOCATOR | Oct 20, 1987 | Substantially Equivalent |
| K873044 | POREX OTOLOGY INSTRUMENTS | Sep 4, 1987 | Substantially Equivalent |
| K872947 | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | Aug 21, 1987 | Substantially Equivalent |
| K863943 | POREX(TM) EYE SPHERE IMPLANT | Feb 27, 1987 | Substantially Equivalent |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Feb 27, 1987 | Substantially Equivalent |
| K870154 | POREX(TM) TISSUE EXPANDER | Feb 24, 1987 | Substantially Equivalent |
| K870182 | POREX(TM) MALAR IMPLANT | Feb 24, 1987 | Substantially Equivalent |
| K870257 | POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. | Feb 24, 1987 | Substantially Equivalent |
| K863939 | POREX(TM) EAR PROSTHESIS | Oct 24, 1986 | Substantially Equivalent |
| K863942 | POREX(TM) NOSE PROSTHESIS | Oct 24, 1986 | Substantially Equivalent |